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DATA COMPILATION #PharmaFlow

DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions

The third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA). DMFs are used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug productsA total of 323 Type II DMFs were submitted during this period, as opposed to 309 submissions in Q3 2024, marking an increase of 4.53 percent. This is the second highest number since 2018. In Q1 2025, 339 Type II filings were recorded.Across all DMF types (II, III, IV, and V), 479 DMFs were filed in Q3 2025, compared to 394 in Q3 2024, representing a 21.57 percent increase. Out of the 323 Type II DMFs submitted in Q3 2025, 40 had completed their review by the end of Q3, reflecting a processing lag between submission and review completion. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available)China maintains its lead while India posts double-digit growth in DMF submissions China and India continued to dominate DMF submissions in Q3 2025. China retained the top spot with 153 Type II DMFs, matching its submission count from Q3 2024. India recorded 131 DMFs, marking a 20.18 percent increase over 109 filings during the corresponding period last year.The United States stood a distant third with 17 filings, compared to 13 in Q3 2024. Among European nations, Italy recorded eight DMFs, doubling its 2024 tally. The Netherlands filed four, up from three. Spain submitted only one DMF, as against seven submitted in Q3 2024. Taiwan made three filings, up from one submitted in Q3 2024. Together, India, China and Taiwan accounted for about 88.9 percent of all Type II DMFs filed during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) China’s Suzhou Ryway Biotech tops corporate tally; India’s Hetero, Biophore followChina’s Suzhou Ryway Biotech led the company-wise tally with 12 DMF submissions in Q3 2025. The company had not filed any DMFs in Q3 2024.India’s Hetero Group followed with nine DMFs, maintaining the same number of filings as Q3 2024. Biophore India Pharmaceuticals ranked third with six DMFs, doubling its count from three last year.Other notable contributors include Sai Sreyas Pharmaceuticals (India) and Shanghai Haoyuan Chemexpress (China), with five DMFs each. Companies such as SNJ Group, Lunan Pharmaceutical, Allsino Pharmaceutical, Shankus Pharma, Jiangxi Xinganjiang Pharmaceutical, Sunpure Extracts, Lee Pharma, Umedica Laboratories, Linhai Tianyu Pharmaceutical and Maithri Drugs filed four DMFs each. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) Olaparib, semaglutide lead molecular filings; Dr. Reddy’s files DMF for edoxaban & tucatinibDr. Reddy’s Laboratories also featured among key DMF filers in Q3 2025, submitting two DMFs — for edoxaban tosylate monohydrate and tucatinib copovidone. Edoxaban tosylate monohydrate (marketed as Savaysa by Daiichi Sankyo) is a prescription anticoagulant used to reduce the risk of stroke and to treat deep vein thrombosis and pulmonary embolism. Patent exclusivity for Savaysa extends until October 2026 in the United States, with no generic currently available.In terms of molecules, the highest number of DMFs were filed for olaparib, semaglutide, ruxolitinib phosphate, ferric carboxymaltose, and vismodegib, with three DMFs each in Q3 2025.Olaparib, sold by AstraZeneca under the brand name Lynparza, saw DMFs being filed by BDR Lifesciences and Intas Pharmaceuticals from India, and by ScinoPharm Taiwan during the quarter.Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk, continued to draw strong interest from API manufacturers. DMFs for semaglutide were filed by three Chinese companies: Yangzhou Aurisco Pharmaceutical, Zhejiang Peptites Biotech, and Fujian Genohope Biotech.Ruxolitinib phosphate, marketed by Incyte as Jakafi, saw three DMFs. Three Indian companies — Alembic Pharmaceuticals, Valary Labs, and Devi Pharmatech — filed DMFs for this API in Q3 2025. Other molecules that received multiple DMF submissions include ferric carboxymaltose (used to treat iron-deficiency anemia) and vismodegib (an oral therapy for basal-cell carcinoma). View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) First-time DMF filings span 17 companies; India leads with nine first-time DMFs The quarter saw first-time DMF filings from 17 companies. India took a lead here with nine first-time DMF filings, followed by China (six), and the US (two).The DMF filings in this quarter included inclisiran sodium (filed by Aurisco Pharmaceutical of China), pacritinib citrate (by TAPI Nl B.V. of the Netherlands), and vosoritide (by Apicore LLC of the US).Out of the 19 first-time DMFs filed in Q3 2025, four completed their Generic Drug User Fee Amendments (GDUFA) review process during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2026: The FDA Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry.Fee rates for fiscal year 2026 were published on July 30, 2025. FDA has revised fees under GDUFA III across all categories. While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY 2025 and FY 2026 User Fee Rates Generic drug fee category Fees rates for FY 2025 Fees rates for FY 2026 Applications: Abbreviated New Drug Application (ANDA) US$ 3,21,920 US$ 3,58,247 Drug Master File (DMF) US$ 95,084 US$ 1,02,584 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 41,580 US$ 43,549 API—Foreign US$ 56,580 US$ 58,549 Finished Dosage Form (FDF)—Domestic US$ 2,31,952 US$ 2,38,943 FDF—Foreign US$ 2,46,952 US$ 2,53,943 Contract Manufacturing Organization (CMO)—Domestic US$ 55,668 US$ 57,346 CMO—Foreign US$ 70,668 US$ 72,346 GDUFA Program: Large size operation generic drug applicant US$ 18,91,664 US$ 19,18,377 Medium size operation generic drug applicant US$ 7,56,666 US$ 7,67,351 Small business generic drug applicant US$ 1,89,166 US$ 1,91,838 Our viewFor several years prior to the pandemic, India had a lead in Type II DMF submissions. In recent years, China has surpassed India in DMF filings. But Q3 2025 numbers indicate that Indian drugmakers are fast catching up. Since DMFs establish trust in APIs from across the world, we feel this healthy competition between drugmakers from the two countries is good for the global pharmaceutical industry.

Impressions: 2855

DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024. Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each. The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders). View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453 US$ 3,21,920 Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427 US$ 2,31,952 FDF—Foreign US$ 2,35,427 US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629 US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852 US$ 7,56,666 Small business generic drug applicant US$ 1,72,963 US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.

Impressions: 9206

NEWS #PharmaBuzz

Granules India Receives Official 2025 CDP Rating

12 Dec 2025

// INDPHARMAPOST

Granules India Completes FDA Inspection Without Observations

04 Dec 2025

// EXPRESSPHARMA

Granules India Opens 2 Centers Of Excellence At IIT Hyderabad

01 Dec 2025

// PRESS RELEASE

Granules Life Gets 1st FDA Approval For Hyderabad facility

11 Nov 2025

// BSE INDIA

Granules India's Facility Secures FDA EIR With 'VAI’

30 Oct 2025

// PRESS RELEASE

Granules India and NIPER S.A.S Nagar Launch Centre of Excellence

06 Sep 2025

// PRESS RELEASE

ALL APIs

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USDMF

01

Acetaminophen Usp

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : Complete

Rev. Date : 2013-06-08

Pay. Date : 2012-11-29

DMF Number : 19804

Submission : 2006-09-28

Status : Active

Type : II

02

Atazanavir Sulfate

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32259

Submission : 2017-12-27

Status : Active

Type : II

03

Avatrombopag Maleate

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 41872

Submission : 2025-07-01

Status : Active

Type : II

04

Bupropion Hydrochloride Usp

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : Complete

Rev. Date : 2021-05-27

Pay. Date : 2021-04-15

DMF Number : 35694

Submission : 2021-03-29

Status : Active

Type : II

05

Cetirizine Hydrochloride, Usp

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : Complete

Rev. Date : 2016-03-23

Pay. Date : 2015-12-14

DMF Number : 30063

Submission : 2016-02-01

Status : Active

Type : II

06

Compresso 95p

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17723

Submission : 2004-09-22

Status : Active

Type : II

07

Compresso Ggf 95 Sa (guaifenesin Gra...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20998

Submission : 2007-10-31

Status : Active

Type : II

08

Compresso Ibu 66s

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20606

Submission : 2007-06-12

Status : Active

Type : II

09

Compresso Ibu 85 Par (ibuprofen Gran...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35886

Submission : 2021-05-18

Status : Active

Type : II

10

Compresso Lsp 33.333 % (losartan Pot...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36088

Submission : 2021-07-12

Status : Active

Type : II

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CEP/COS

01

Atazanavir sulfate

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Certificate Numbers : CEP 2020-279 - Rev 01

Status : Valid

Issue Date : 2024-06-10

Type : Chemical

Substance Number : 2898

02

Rifaximin

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Certificate Numbers : CEP 2012-146 - Rev 02

Status : Valid

Issue Date : 2024-06-10

Type : Chemical

Substance Number : 2362

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JDMF

01

Acetaminophen

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Contact Supplier

India

Digital Content

Registration Number : 228MF10061

Registrant's Address : 2nd Floor, 3rd Block, My Home Hub, Madhapur, Hyderabad, Telangana 500081 India

Initial Date of Registration : 2016-02-24

Latest Date of Registration : 2016-02-24

02

Metformin Hydrochloride

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Contact Supplier

India

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Date of Issue : 2025-08-01

Valid Till : 2028-07-02

Written Confirmation Number : WC-0116

Address of the Firm : H.NO. 6-5 & 6-11, TEMPLE ROAD,...

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KDMF

01

Acetaminophen

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Registrant Name : Daeshin Pharmaceutical Co., Ltd.

Registration Date : 2005-09-15

Registration Number : 20050915-32-C-198-10

Manufacturer Name : Granules India Ltd

Manufacturer Address : H. No.: 6-5 & 6-11, Temple Road, Bonthapally Village, Gummadidala Mandal, Sangareddy ...

02

Acetaminophen

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Registrant Name : Insung Trading Co., Ltd.

Registration Date : 2023-03-29

Registration Number : 20050915-32-C-198-10(B)

Manufacturer Name : Granules India Ltd

Manufacturer Address : H.No.6-5 & 6-11, Temple Road, Bonthapally Village, Gummadidala Mandal, Sangareddy Dis...

03

Acetaminophen

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Registrant Name : Johnson & Johnson Korea Sales Co., Ltd.

Registration Date : 2023-03-03

Registration Number : 20050915-32-C-198-10(A)

Manufacturer Name : Granules India Ltd

Manufacturer Address : H.No.6-5 & 6-11, Temple Road, Bonthapally Village, Gummadidala Mandal, Sangareddy Dis...

04

fexofenadine hydrochloride

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2025-03-11

Registration Number : 20250311-209-J-1810

Manufacturer Name : M/s. Granules India Limited (U...

Manufacturer Address : Plot No.08, Jawaharlal Nehru Pharma City, Parawada Mandal, Visakhapatnam Dist 531 019...

05

Guaifenesin

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Registrant Name : Hwail Pharmaceutical Co., Ltd.

Registration Date : 2021-11-30

Registration Number : 20210309-211-J-857(3)

Manufacturer Name : Granules India Limited

Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, T...

06

Guaifenesin

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Registrant Name : Insung Trading Co., Ltd.

Registration Date : 2021-03-09

Registration Number : 20210309-211-J-857

Manufacturer Name : Granules India Limited

Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, T...

07

Guaifenesin

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Registrant Name : Daeshin Pharmaceutical Co., Ltd.

Registration Date : 2021-07-05

Registration Number : 20210309-211-J-857(2)

Manufacturer Name : Granules India Limited

Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, T...

08

Guaifenesin

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Registrant Name : IMCD Korea Co., Ltd.

Registration Date : 2021-06-04

Registration Number : 20210309-211-J-857(1)

Manufacturer Name : Granules India Limited

Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist-500 055.,Tela...

09

Levocetirizine hydrochloride

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

Registration Date : 2009-07-20

Registration Number : 20090720-40-C-258-15

Manufacturer Name : Granules India Limited_x000D_

Manufacturer Address : Plot No 8, Jawaharlal Nehru Pharma City, Tadi Village, Parawada Mandal, Vitsakhapatna...

10

Levocetirizine hydrochloride

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Registrant Name : Dongkwang Pharmaceutical Co., Ltd.

Registration Date : 2016-02-25

Registration Number : 20090720-40-C-258-15(2)

Manufacturer Name : Granules India Limited

Manufacturer Address : Plot No 8, Jawaharlal Nehru Pharma City, Tadi Village, Parawada Mandal, Vitsakhapatna...

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NDC API

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LISTED APIs

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Drugs in Development

01 Granules India Limited

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Lead Product(s) : Lisdexamfetamine Dimesylate,Inapplicable

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules Strengthens ADHD Portfolio with FDA Approval for Lisdexamfetamine Dimesylate

Details : FDA approved Lisdexamfetamine Dimesylate Capsules, a bioequivalent and therapeutically equivalent to the reference listed drug, Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder.

Product Name : Vyvanse-Generic

Product Type : Controlled Substance

Upfront Cash : Inapplicable

January 30, 2025

02 Granules India Limited

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Lead Product(s) : Lisdexamfetamine Dimesylate,Inapplicable

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules India Limited Announces FDA Approval for ADHD Treatment

Details : FDA approved Lisdexamfetamine Dimesylate Tablets, a bioequivalent and therapeutically equivalent to the reference listed drug, Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder.

Product Name : Vyvanse-Generic

Product Type : Controlled Substance

Upfront Cash : Inapplicable

December 17, 2024

03 Granules India Limited

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Lead Product(s) : Bupropion Hydrochloride,Inapplicable

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules Announces ANDA Approval for Bupropion Hydrochloride Extended-Release Tablets

Details : FDA approved bupropion hydrochloride extended-release tablets USP (SR) are bioequivalent and therapeutically equivalent to Wellbutrin SR sustained-release tablets.

Product Name : Wellbutrin SR-Generic

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 18, 2024

04 Granules India Limited

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Lead Product(s) : Glycopyrronium Bromide,Inapplicable

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules India Gets USFDA Nod for Generic Glycopyrrolate Oral Solution

Details : Cuvposa is an anticholinergic indicated to reduce chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling.

Product Name : Cuvposa-Generic

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 20, 2024

05 Granules India Limited

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Lead Product(s) : Trazodone Hydrochloride,Inapplicable

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules India Gains ANDA approval for Trazodone Tablets

Details : Desyrel-Generic (trazodone hydrochloride) is a selective serotonin reuptake inhibitor indicated for the treatment of patients with major depressive disorder.

Product Name : Desyrel-Generic

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 09, 2024

06 Granules India Limited

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Lead Product(s) : Pantoprazole Sodium,Inapplicable

Therapeutic Area : Gastroenterology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules India Limited Received ANDA Approval for Pantoprazole Sod Delayed-Release Tablets

Details : Pantoprazole Sodium Delayed-Release tablets are indicated for short-term treatment of Erosive Esophagitis Associated with GERD and Pathological Hypersecretory Conditions.

Product Name : Protonix-Generic

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 13, 2023

07 Granules India Limited

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Lead Product(s) : Sildenafil Citrate,Inapplicable

Therapeutic Area : Cardiology/Vascular Diseases

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules India Limited Received ANDA Approval for Sildenafil for Oral Suspension

Details : Sildenafil is an inhibitor of cyclic GMP specific PDE type 5, the predominant enzyme metabolizing cyclic GMP in the corpus cavernosum. It is indicated for pulmonary arterial hypertension in adults.

Product Name : Revatio-Generic

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 03, 2023

08 Granules India Limited

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Lead Product(s) : Esomeprazole Magnesium,Inapplicable

Therapeutic Area : Gastroenterology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules India Gets USFDA Nod for Generic Drug Used for Short-term Treatment of Heartburn

Details : Esomeprazole magnesium delayed-release capsules is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease and NSAID-associated gastric ulcer.

Product Name : Nexium-Generic

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 19, 2023

09 Granules India Limited

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Lead Product(s) : Losartan Potassium,Hydrochlorothiazide

Therapeutic Area : Cardiology/Vascular Diseases

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules India Limited Received ANDA Approval for Losartan and Hydrochlorothiazide Tablets

Details : Generic of Losartan potassium and hydrochlorothiazide tablets are been approved by FDA, indicated for hypertension to lower blood pressure and to reduce the risk of stroke.

Product Name : Cozaar-Generic

Product Type : Hormone

Upfront Cash : Inapplicable

September 30, 2023

10 Granules India Limited

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Lead Product(s) : Ibuprofen,Inapplicable

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

FDA Approves Granules' OTC Equivalent Of Advil Dual Action Tablets

Details : The company has received approval from the US Food and Drug Administration (USFDA) for generic version for Acetaminophen and Ibuprofen tablets (250 mg/125 mg) indicated for pain and inflammation.

Product Name : Advil-Generic

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 14, 2023

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FDF Dossiers

01

Brand Name : ACETAMINOPHEN

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : OTC

Registration Country : USA

Dosage Form : TABLET, EXTENDED RELEASE...

Dosage Strength : 650MG

Packaging :

Approval Date : 2019-04-16

Application Number : 211544

Regulatory Info : OTC

Registration Country : USA

02

Brand Name : ARTHRITIS PAIN RELIE...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

Dosage Form : TABLET (EXTENDED-RELEASE...

Dosage Strength : 650MG

Packaging :

Approval Date :

Application Number : 2519631

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

03

Brand Name : ACETAMINOPHEN EXTRA ...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

Dosage Form : TABLET

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number : 2525844

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

04

Brand Name : MUSCLE & BODY

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

Dosage Form : TABLET (EXTENDED-RELEASE...

Dosage Strength : 650MG

Packaging :

Approval Date :

Application Number : 2534851

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

05

Brand Name : ACETAMINOPHEN EXTRA ...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

Dosage Form : TABLET

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number : 2538407

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

06

Brand Name : ACETAMINOPHEN EXTRA ...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

Dosage Form : TABLET

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number : 2552159

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

07

Brand Name : ACETAMINOPHEN, ASPIR...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : OTC

Registration Country : USA

ACETAMINOPHEN; ASPIRIN; CAFFEINE

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG;250MG;65MG

Packaging :

Approval Date : 2021-02-23

Application Number : 214039

Regulatory Info : OTC

Registration Country : USA

08

Brand Name : BUTALBITAL AND ACETA...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : RX

Registration Country : USA

ACETAMINOPHEN; BUTALBITAL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG;50MG

Packaging :

Approval Date : 2019-11-22

Application Number : 213115

Regulatory Info : RX

Registration Country : USA

09

Brand Name : BUTALBITAL, ACETAMIN...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : RX

Registration Country : USA

Dosage Form : TABLET;ORAL

Dosage Strength : 325MG;50MG;40MG

Packaging :

Approval Date : 2008-12-01

Application Number : 40864

Regulatory Info : RX

Registration Country : USA

10

Brand Name : BUTALBITAL, ACETAMIN...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : RX

Registration Country : USA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG;50MG;40MG

Packaging :

Approval Date : 2020-04-08

Application Number : 213321

Regulatory Info : RX

Registration Country : USA

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FDA Orange Book

01

Brand Name : ACETAMINOPHEN

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code :

Dosage Form : TABLET, EXTENDED RELEASE; ORAL

Dosage Strength : 650MG

Approval Date : 2019-04-16

Application Number : 211544

RX/OTC/DISCN : OTC

RLD : No

TE Code :

02

Brand Name : ACETAMINOPHEN, ASPIR...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code :

ACETAMINOPHEN; ASPIRIN; CAFFEINE

Dosage Form : TABLET; ORAL

Dosage Strength : 250MG;250MG;65MG

Approval Date : 2021-02-23

Application Number : 214039

RX/OTC/DISCN : OTC

RLD : No

TE Code :

Product
Web Link

03

Brand Name : BUTALBITAL AND ACETA...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AA

ACETAMINOPHEN; BUTALBITAL

Dosage Form : CAPSULE; ORAL

Dosage Strength : 300MG;50MG

Approval Date : 2019-11-22

Application Number : 213115

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

04

Brand Name : BUTALBITAL, ACETAMIN...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AA

Dosage Form : TABLET; ORAL

Dosage Strength : 325MG;50MG;40MG

Approval Date : 2008-12-01

Application Number : 40864

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product
Web Link

05

Brand Name : BUTALBITAL, ACETAMIN...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AA

Dosage Form : CAPSULE; ORAL

Dosage Strength : 300MG;50MG;40MG

Approval Date : 2020-04-08

Application Number : 213321

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

06

Brand Name : HYDROCODONE BITARTRA...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AA

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Dosage Form : TABLET; ORAL

Dosage Strength : 325MG;5MG

Approval Date : 2020-01-03

Application Number : 211729

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product
Web Link

07

Brand Name : HYDROCODONE BITARTRA...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AA

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Dosage Form : TABLET; ORAL

Dosage Strength : 325MG;7.5MG

Approval Date : 2020-01-03

Application Number : 211729

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product
Web Link

08

Brand Name : HYDROCODONE BITARTRA...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AA

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Dosage Form : TABLET; ORAL

Dosage Strength : 325MG;10MG

Approval Date : 2020-01-03

Application Number : 211729

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

09

Brand Name : ACETAMINOPHEN AND IB...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code :

ACETAMINOPHEN; IBUPROFEN

Dosage Form : TABLET; ORAL

Dosage Strength : 250MG;125MG

Approval Date : 2023-07-13

Application Number : 216592

RX/OTC/DISCN : OTC

RLD : No

TE Code :

10

Brand Name : OXYCODONE AND ACETAM...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AA

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Dosage Form : TABLET; ORAL

Dosage Strength : 325MG;2.5MG

Approval Date : 2019-10-31

Application Number : 211708

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Only 10 entries up to this point, click to access all

Canada

01

Brand Name : ARTHRITIS PAIN RELIE...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

Dosage Form : TABLET (EXTENDED-RELEASE)

Dosage Strength : 650MG

Packaging :

Approval Date :

Application Number : 2519631

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

02

Brand Name : ACETAMINOPHEN EXTRA ...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

Dosage Form : TABLET

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number : 2525844

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

03

Brand Name : MUSCLE & BODY

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

Dosage Form : TABLET (EXTENDED-RELEASE)

Dosage Strength : 650MG

Packaging :

Approval Date :

Application Number : 2534851

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

04

Brand Name : ACETAMINOPHEN EXTRA ...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

Dosage Form : TABLET

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number : 2538407

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

05

Brand Name : ACETAMINOPHEN EXTRA ...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

Dosage Form : TABLET

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number : 2552159

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

06

Brand Name : METFORMIN TABLETS

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : Prescription

Registration Country : Canada

METFORMIN HYDROCHLORIDE

Dosage Form : TABLET

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number : 2514486

Regulatory Info : Prescription

Registration Country : Canada

07

Brand Name : METFORMIN TABLETS

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : Prescription

Registration Country : Canada

METFORMIN HYDROCHLORIDE

Dosage Form : TABLET

Dosage Strength : 850MG

Packaging :

Approval Date :

Application Number : 2514494

Regulatory Info : Prescription

Registration Country : Canada

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Listed Dossiers

01

Brand Name : Amphetamine Sulphate

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info :

Registration Country : India

Dosage Form : Immediate Release Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

02

Brand Name : Amphetamine Sulphate

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info :

Registration Country : India

Dosage Form : Immediate Release Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

03

Brand Name : Mixed Amphetamines

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info :

Registration Country : India

Dosage Form : Extended Release Capsule

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

04

Brand Name : Mixed Amphetamines

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info :

Registration Country : India

Dosage Form : Extended Release Capsule

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

05

Brand Name : Mixed Amphetamines

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info :

Registration Country : India

Dosage Form : Extended Release Capsule

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

06

Brand Name : Mixed Amphetamines

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info :

Registration Country : India

Dosage Form : Extended Release Capsule

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

07

Brand Name : Mixed Amphetamines

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info :

Registration Country : India

Dosage Form : Extended Release Capsule

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

08

Brand Name : Mixed Amphetamines

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info :

Registration Country : India

Dosage Form : Extended Release Capsule

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

09

Brand Name : Mixed Amphetamines

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info :

Registration Country : India

Dosage Form : Immediate Release Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

10

Brand Name : Mixed Amphetamines

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info :

Registration Country : India

Dosage Form : Immediate Release Tablet

Dosage Strength : 7.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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KEY PRODUCTS

TOP RANKED SUPPLIER FOR:

Inspections and registrations

Check the inspections & registration from this company

FDA

01 FDA Audited

USA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

District Decision : No Action Indicated

Inspection End Date : 2024-04-12

City : Parawada Mandal

State :

Country/Area : India

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2024-04-12

Product
Web Link

02 FDA Audited

USA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

District Decision : Voluntary Action Indicated

Inspection End Date : 2023-12-15

City : Chantilly

State : Virginia

Country/Area : U.S.A

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2023-12-15

Product
Web Link

03 FDA Audited

USA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

District Decision : No Action Indicated

Inspection End Date : 2023-08-03

City : Chantilly

State : Virginia

Country/Area : U.S.A

Zip :

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2023-08-03

Product
Web Link

04 FDA Audited

USA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

District Decision : No Action Indicated

Inspection End Date : 2023-06-30

City : Visakhapatnam

State :

Country/Area : India

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2023-06-30

Product
Web Link

05 FDA Audited

USA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

District Decision : No Action Indicated

Inspection End Date : 2023-06-23

City : Secunderabad

State :

Country/Area : India

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2023-06-23

Product
Web Link

06 FDA Audited

USA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-07-22

City : Chantilly

State : Virginia

Country/Area : U.S.A

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-07-22

Product
Web Link

07 FDA Audited

USA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

District Decision : Voluntary Action Indicated

Inspection End Date : 2020-02-14

City : Medchal-Malkhajgiri Distr...

State :

Country/Area : India

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2020-02-14

Product
Web Link

08 FDA Audited

USA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

District Decision : Voluntary Action Indicated

Inspection End Date : 2020-01-16

City : Parawada Mandal

State :

Country/Area : India

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2020-01-16

Product
Web Link

09 FDA Audited

USA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-07-26

City : Sangareddy District

State :

Country/Area : India

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-07-26

Product
Web Link

10 FDA Audited

USA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-03-23

City : Secunderabad

State :

Country/Area : India

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-03-23

Product
Web Link

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EDQM

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GDUFA

01 GDUFA fees paid

USA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Paid in : 2025

API Manufacturer :

FDF Manufacturer : FDF MANUFACTURE

Facility Name : Granules India Limited

Business Address : Sy.No. 160/A, 161/E, 162, 17...

FEI Number : 3004097901

Country : India

Paid in : 2025

Product
Web Link

02 GDUFA fees paid

USA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Paid in : 2025

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : Granules India Limited

Business Address : H.No.6-5 & 6-11 Temple Road ...

FEI Number : 3003723146

Country : India

Paid in : 2025

Product
Web Link

03 GDUFA fees paid

USA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Paid in : 2025

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : Granules India Limited

Business Address : Plot No.15 A/1 Phase-III, ID...

FEI Number : 3001319869

Country : India

Paid in : 2025

Product
Web Link

04 GDUFA fees paid

USA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Paid in : 2025

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : Granules India Limited

Business Address : Unit-IV, Plot No. 8 Jawaharl...

FEI Number : 3006583291

Country : India

Paid in : 2025

Product
Web Link

05 GDUFA fees paid

USA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Paid in : 2025

API Manufacturer :

FDF Manufacturer :

Facility Name : Granules India Limited

Business Address : Unit-V, Plot No. 30 Jawaharl...

FEI Number : 3012884557

Country : India

Paid in : 2025

Product
Web Link

06 GDUFA fees paid

USA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Paid in : 2025

API Manufacturer :

FDF Manufacturer : FDF MANUFACTURE

Facility Name : Granules Pharmaceuticals Inc.

Business Address : 3701 & 3725 Concorde Parkway...

FEI Number : 3011585184

Country : India

Paid in : 2025

Product
Web Link